Senators: Tenn. officials more decisive than FDA

Nov. 15, 2012
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Marion Kainer, director of the Healthcare Associated Infections & Antimicrobial Resistance Program at the Tennessee Department of Health, testifies before a hearing Thursday in Washington. The hearing was called over the meningitis outbreak. / Joe Brier, Gannett

by Paul C. Barton, Gannett Washington Bureau

by Paul C. Barton, Gannett Washington Bureau

WASHINGTON -- As Congress continues to express dismay at how regulators failed to prevent this fall's meningitis outbreak, Tennessee got lauded as a bright spot in the public health system during a Senate hearing Thursday.

Lawmakers also heard how much worse it could have been for the state if not for state officials' decisive actions.

Republican Sen. Lamar Alexander, joined by Sens. Tom Harkin, D-Iowa, and Barbara Mikulski, D-Md., were among those who singled out the actions of the Tennessee Department of Health during a hearing of the Health, Education, Labor and Pensions Committee.

From Sept. 18, when the department learned of the case of Eddie Lovelace, suffering the aftereffects from a steroid injection at a Nashville clinic, to Oct. 4, when it ordered all Tennessee health facilities to stop using medicines from the New England Compounding Center in Framingham, Mass., state officials were exemplary in their performance, lawmakers said. They noted how the department, led by Dr. Marion Kainer, sent out continuing alerts to the Centers for Disease Control and Prevention, the Food and Drug Administration, plus officials in other states, about the danger of the drugs.

Steroid drugs from NECC are now connected to 461 cases of meningitis nationwide and 81 in Tennessee. The state leads the nation in meningitis-related deaths with 13.

If Tennessee had delayed acting for as little as nine additional days, the state would have suffered at least five more deaths and more than 50 additional cases, Kainer testified.

The current crisis is far from over, Kainer added.

"In Tennessee, we still have many patients hospitalized and suffering from complications and others who are exposed and frightened that they may become infected," she said.

But that didn't stop Mikulski from praising her. "Tennessee was really doing their public health job," the Maryland senator said.

And Alexander, speaking to reporters afterward, contrasted his home state's efforts with those of the Massachusetts Board of Pharmacy, which he called "incompetent," and the FDA, which he called "nearly incompetent."

"Tennessee public health officials deserve a gold medal," he said.

In a significant political development during the hearing, David Miller, representing the International Academy of Compounding Pharmacists, signaled his group would no longer oppose legislation to clarify FDA authority over large-scale compounding. The group had lobbied against a 2007 bill that would have made that clarification. It was sponsored by the late senator Edward M. Kennedy, D-Mass.

Alexander said he sees bipartisan legislation to make that change being introduced at the start of the 113th Congress in January. It's a bill that should have fairly clear sailing, he said afterward

"I don't think the lobbying forces are going to have any luck on this one," Alexander said.

Meanwhile, the FDA, for the second Capitol Hill hearing in as many days, continued to face strong bipartisan criticism about its failure to take decisive action against NECC at several points over the past decade.

But Margaret Hamburg, who President Obama appointed commissioner in 2009, continued to argue her agency is hindered by a regulatory structure that is "limited, unclear and contested" when it comes to large-scale compounders like NECC.

For the most part, senators weren't buying her arguments, saying the agency had powers it didn't use.

If the FDA gets additional authority, Sen. Richard Blumenthal, D-Conn., said, "Will the FDA use this authority more vigorously than it has used its authority to date?"

He added, "I think the conclusion is inescapable that this tragedy could have and should have been prevented."

Sen. Pat Roberts, R-Kansas, noted various inspections and other unfavorable reports about NECC the FDA knew about, including its own warning letter sent to the company in 2006.

"This has been going on since 2002. It's amazing," Roberts said in a booming voice that startled some of the hundreds in the audience.

"It took all this time and nobody did anything."

But Hamburg repeatedly said her agency was hampered under existing law, including confusion caused by differing decisions from the 9th and 5th U.S. Circuit Courts of Appeal. The two circuits, in deciding separate cases, came to differing conclusions about whether a 1998 update to Depression-era legislation gave the FDA authority over large-scale compounders.

In contrast, the FDA has long left regulation of small-scale compounding done at neighborhood pharmacies to the states, even though many believe 1938 legislation gives it authority over those.

Alexander said it's time to decide "whose flag is on the pole" when it comes to overseeing the larger compounders that fall into what Hamburg called a "regulatory crazy quilt" and "gray area."

In Tennessee, there are 30 to 50 drug businesses that would fit that category, Alexander said.

Between state and federal officials now, Alexander told reporters afterward, "My biggest frustration is that nobody's at fault."